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Biosimilars Conference

Session 2: Biosimilars During a Pandemic

Session Chair(s)

Laura  McKinley, PhD

Laura McKinley, PhD

  • Director, Global Regulatory Policy and Intelligence
  • Pfizer Inc, United States
As the world continues to navigate the COVID-19 pandemic what will the impact be to biosimilars? This session will discuss the ways biosimilar stakeholders are adjusting to the COVID-19 pandemic to navigate and execute in the new normal. Panelists will present the regulatory perspectives, customer view, and potential impacts to access and uptake.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize the short and long-term regulatory impacts of COVID-19 on biosimilar development and approvals
  • Discuss the customer perspective of pandemic implications to biosimilar use
  • Debate the short and long-term impacts of COVID-19 on access and uptake


Peter P. Stein, MD


Peter P. Stein, MD

  • Director, Office of New Drugs, CDER
  • FDA, United States
Sean  McGowan, MBA


Sean McGowan, MBA

  • Senior Director, Biosimilars
  • AmerisourceBergen, United States
Juliana Marguerite Reed, MS


Juliana Marguerite Reed, MS

  • Vice President, Corporate Affairs, Global I & I and Biosimilars Lead
  • Pfizer, Inc., United States